There is a need to provide mobile, compact, but multi-functional carts for use at point-of-care in a therapeutic setting (e.g., hospital surgical suites, surgical center, pain management center, etc.). There also is a need to be able to remotely control instrumentation that is not compatible with the instrumentation being present in a critical care setting, such as an operating room. The lack of this type of multi-functional cart hampers the processing of samples taken from patients; samples which need to be processed under strict regulation and control. Ideally, in one embodiment such a multi-functional cart would support sample ID tracking (i.e., bar coding option), have a work surface for sample processing, is able to display in real time the status of instrumentation remote to the location of the work station, is able remotely to control and schedule the instrumentation, has two-way communication capability, has an inventory tracking function, can issue reports to various recipients (e.g., the attending surgeon), among other features to support the functioning of the instrumentation and the process provided at point-of-care. In another embodiment, the multi-functional cart would itself house instrumentation to process patient samples, as well as the other features and capabilities already described above. In another embodiment, the multi-functional cart would itself house instrumentation to perform on-site analysis of the patient samples in near-real or real time, the results of which would be processed, computed, recorded and reported by the other capabilities of the multi-functional cart without further manual manipulation.
Separating cells of interest out of patient samples and their biological fluids has been performed for many years, and usually is based on the application of centrifugation. For processing systems to be of use in providing cellular therapy at point of care, the processing technology should be sterilizable and a “closed system”, which means that there is no exposure of the biological fluid and the separated cell components to adventitious agents. Other factors that determine the utility of such a processing system is the composition of the cell preparation, the viability of the cells of interest and the volume in which the cells are collected. Another requirement for such technology is to provide for the facile handling of various types of biological fluids, ranging from bone marrow aspirate, whole blood, fluid obtained from subcutaneous tissue depots, among other fluids of biological origin. One of the objectives of handling such biological fluids is to provide for concentration of cell-free subcomponents of such biological fluids.
There are no known technology platforms that embody all of the technical innovations of the disclosed invention. There are examples of integrated processing systems that can process some of the biological fluids contemplated in this disclosure, but not all such relevant fluids. For example, the Cellution Instrument (Cytori, San Diego, Calif.) is portrayed as being capable of performing enzymatic digestion of adipose tissue to produce a cell preparation. Another system, Syngen-1000 (Synergenesis, Sacramento, Calif.) is designed to concentrate cells from cord blood, bone marrow aspirate and lipoaspirate fluid. However, the Syngen-1000 doesn't have the capability to concentrate biological fluids like platelet poor plasma (PPP) to produce a concentrated fluid with elevated levels of proteins like fibrinogen. There are no such systems available in the marketplace that serve the functions of a work station as well as accommodating the sample processing technology for producing therapeutically beneficial autologous cell and biological fluid preparations for use at point-of-care.
The claimed invention sets forth an automated work-station that fulfills all of these requirements, thereby facilitating the processing of patient samples in full compliance with facility and other regulations applicable for dealing with patients in a medical setting.